Legal & Regulatory Feature

Treace Medical Receives Lapiplasty® Patent

Walter Eisner • Fri, April 28th, 2017

Last June we reported on Treace Medical Concepts, Inc., a small Florida company founded in early 2014 with a proprietary bunion deformity treatment called Lapiplasty®.

On April 18, 2017, the company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,622,805 which broadly covers the methods of multi-planar bunion correction embodied by the Lapiplasty® Procedure. This, according to the company, represents the first to issue in an "aggressive" pipeline of more than 20 patent applications held by the company on its system and related concepts.

According to CEO John Treace, “Bunion surgical outcomes have historically been associated with high rates of recurrence and patient dissatisfaction. Studies indicate a significant contributor to deformity recurrence to be failure to correct frontal plane rotation of the metatarsal bone (the third plane of the deformity)."

Treace says the procedure was designed to realign and correct all three planes of the bunion deformity in a straightforward and reproducible manner, which he believes will demonstrate improved clinical outcomes over time. “This patent issuance represents an exciting milestone for our company as it embodies the key surgical steps required to perform the breakthrough Lapiplasty® Procedure involving our novel instrumentation and implants.”

The Patent

The patent describes, "Methods for temporarily fixing an orientation of a bone or bones. Methods of correcting a bunion deformity. Bone positioning devices. Methods of using a bone positioning device. Bone preparation guides. Methods or using a bone preparation guide."

The development of Lapiplasty® began in mid-2014 when surgeon designers identified bunion surgery as a procedure that lacked reliability and was universally frustrating. It had an unacceptably high recurrence and complication rates associated with many of the popular osteotomy procedures.

The surgeons presented the idea of attacking bunion deformity by way of a “three plane” correctional procedure. Treace’s team developed an instrumentation and fixation system to make the procedure reproducibly successful in any foot and ankle surgeon’s hands.

For those who like to dig a little deeper into the details of the patent documents, here is how the embodiments of the invention are described:

Embodiments of the present invention include methods for temporarily fixing an orientation of a bone or bones. In the method of positioning a bone includes the steps of moving a bone from an anatomically misaligned position to an anatomically aligned position with respect to another bone and preparing an end of the bone and a facing end of another bone.

In some embodiments, at least one bone end is prepared after the bone is moved into the aligned position.

In some embodiments, the bone is anatomically aligned in more than one plane such that the bone both translates and rotates in response to a moving force.

One embodiment includes a method of correcting a bunion deformity. The method has the steps of moving a first metatarsal from an anatomically misaligned position with respect to a second metatarsal to an anatomically aligned position with respect to the second metatarsal by applying a force to the first metatarsal, the force moving the first metatarsal to correct an alignment in more than one plane. The method can also include preparing an end of the first metatarsal and preparing an opposing end of a medial cuneiform and the first metatarsal fusion.

Embodiments or the invention also include a bone positioning device and a bone preparation guide, and methods or using such guides.

As we previously reported, the founders of Treace Medical are the same people who coined the term "kyphoplasty" and include the former CEO and Chairman of the Board of Kyphon and its key executives who helped build Kyphon.

I have been a podiatry, orthopedic distributor since 1983 based in Sioux Falls, South Dakota. I have reps in Rochester Minnesota, Des Moines Iowa, Omaha Nebraska. I have show the surgical procedure to several podiatrists in these markets and they were all very interested. Do you have distribution opportunities in any of these markets. Thank you.

Leave a Reply

MedShape: 510(k) for Bone Tether Plate

Elizabeth Hofheinz, M.P.H., M.Ed. • Fri, February 6th, 2015

MedShape, Inc. has announced that the company has received FDA 510(k) clearance for its FastForward Bone Tether Plate, a product featuring the company’s latest technology platform: the 3D printing of medical grade titanium alloy “that allows for the fabrication of devices with complex and/or customizable geometries.”

The plate is the main component of the FastForward Bunion Correction System, “a new approach to surgically correct hallux valgus deformities that preserves and protects the native bone anatomy.” According to the February 2, 2015 news release, tethering suture material between the first and second metatarsals is one alternative bone-sparing approach to treatment. “However, peer-reviewed studies have reported the occurrence of second metatarsal fractures due to stress concentrations created by the suture-button implant and the requirement to drill through the second metatarsal.”

“The FastForward Bone Tether Plate represents a breakthrough in bunion correction by allowing suture tape to be securely and safely wrapped around the second metatarsal eliminating the need to drill through the bone. Thanks to the new 3D printing technology, the Bone Tether Plate is equipped with several unique design features including an overall geometry that closely matches the second metatarsal anatomy so that stresses are optimally distributed on the bone and a looped portion that allows suture tape to pass and securely hold the plate in place without the need for bone screws.”

MedShape has also received 510(k) clearance for its FastForward PEEK Screw System, to be used in conjunction with the Bone Tether.

“The FastForward system aligns with MedShape’s continued mission to develop and commercialize innovative medical devices from cutting edge materials and manufacturing technologies to address significant clinical needs, ” said Ken Gall, Ph.D., chief technology officer of MedShape and professor of Materials Science and Engineering at the Georgia Institute of Technology. “We are in the early stages of tracking clinical outcomes with this new surgical approach and are excited to extend the 3D printing material platform towards the development of other implants.”

Dr. Gall told OTW, “In order to address the clinical demands associated with bunion procedures, it was important that we develop a device that would fit securely around the 2nd metatarsal while protecting the bone from large stress risers.

Spine Doc Wins $20.3 Million Against Medtronic

Walter Eisner • Wed, November 23rd, 2016

In early November, a federal jury in Texas awarded Mark Barry, M.D., $20.3 million after finding that Medtronic, plc "actively induced" infringement of patents covering spinal deformity repair services held by Barry, who sued the company in 2014, alleging infringement of a trio of patents. Barry claimed that the company's CD Horizon Legacy spinal system infringed on his patent entitled, "System and Method for Aligning Vertebrae in the Ameliorating of Aberrant Spinal Column Deviation Conditions."

According to court documents, the patent claims cover a "method for aligning vertebrae with a tool that allows a single surgeon to rotate the spinal column as a whole, using pedicle screws, spinal rods and a 'pedicle screw cluster derotational tool.’" The case went to trial November 3, 2016 and wrapped up a week later on Veteran’s Day. The 10 jurors deliberated for about five hours before coming to a unanimous verdict.

After the week-long trial, the jury awarded nearly $15.1 million for infringement of one of the patents in the U.S.; more than $2.6 million for U.S. infringement of the second patent; and another $2.6 million for infringement of that patent outside the U.S. The third patent had been dropped from the suit after Barry licensed the patents to Zimmer Biomet Holdings, Inc.

MassDevice reported on November 15, 2016, that Barry had also tried to drag Globus Medical, Inc., into the case. He wanted the U.S. District Court for Eastern Pennsylvania to subpoena Globus for documents related to its competing Revere device, alleging that the discovery was relevant because Globus copied Barry’s system in developing the Revere device. But Judge Harvey Bartle III found that Barry did not offer any factual basis for his allegation that Globus copied his patent.”

In August 2015, we reported that after a motion from the company to dismiss the case, Judge Ron Clark ruled that he would not dismiss the case, but also said the company won't be subject to pre-case damages on all of the patents. Medtronic has asked for a summary judgement against Barry's suit alleging prior public use of the invention and that Barry failed to mark the patents and was therefore not entitle to pre-suit damages.

KFx Medical Beats Back Arthrex Lawsuit

Walter Eisner • Thu, January 21st, 2016

On January 12, 2016, the U.S. District Court in Trenton, New Jersey, ruled in favor of KFx Medical Corporation in a lawsuit filed by Arthrex Incorporated on July 31, 2015. The two companies have been involved in an ongoing patent infringement dispute.

According to a January 19, 2016 KFx press release, Arthrex sued KFx and Joe Tauro, M.D. alleging misappropriation of trade secrets, unfair competition, breach of contract and interference. KFx filed a response denying the allegations and asserting that Arthrex's claims were barred by a judgement in favor of KFx in its earlier successful patent infringement lawsuit against Arthrex. KFx also asserted new counterclaims for patent infringement based on Arthrex's infringement of U.S. Patent Nos. 8, 926, 663 ("the '663 patent") and 9, 044, 226 ("the '226 patent").

KFx and Tauro moved to have Arthrex’s lawsuit dismissed. The New Jersey Court, according to KFx, agreed and dismissed the case. KFx patent infringement counterclaims against Arthrex continue.

In the original patent suit by KFx against Arthrex, a federal jury in southern California found that Arthrex infringed KFx's U.S. Patent No. 7, 585, 311 and two other patents. The jury, according to KFx, found the patents were valid and awarded KFx $29 million in damages. Arthrex appealed, but the U.S. Court of Appeals for the Federal Circuit ruled in favor of KFx.

The District Court later awarded additional damages and interest to bring the total judgment to over $35 million. Arthrex asked for a rehearing, but was denied. Arthrex then went to the U.S. Supreme Court with a writ of certiorari, but the Court denied the petition.

After the Supreme Court victory, Tate Scott, KFx's president and CEO said, “Small companies can indeed win and defend their intellectual property from much much larger companies. The Supreme Court's ruling today has confirmed KFx patents are valid and infringed by Arthrex. We will continue to require other infringers to respect our intellectual property.”

KFx Medical is a private company headquartered in Solana Beach, California. The company was founded in 2003 to develop products for tissue fixation in orthopedic procedures on the shoulder, knee, foot, and ankle.

Arthrosurface Self-Cinching Suture Cleared by FDA

Walter Eisner • Mon, August 25th, 2014

Arthrosurface, Inc.'s KISSloc Suture System has been given FDA 510(k) clearance.

According to an August 25, 2014 company press release, the system is a mini plate and suture implant intended for the correction of a hallux valgus (bunion) deformity. It consists of two low profile plates and a self-cinching suture construct which reduces the intramedullary angle between the first and second metatarsal bones.

Bunion Deformity

A bunion is an abnormality of the big toe that is highlighted by enlargement of the metatarsal head and an abduction of the toe. The company says it is the most common foot deformity with data showing that approximately 23% of people aged 18-65 and 35% of people over the age of 65 have developed bunions. Wearing ill-fitting shoes over a long period of time is one of the main causes of bunions, although a patient’s genetic material may also contribute.

Recent peer-reviewed publications, according to the company, have reported various second metatarsal stress fractures associated with competitive suture–button fixation of hallux valgus. "The objective of the [Arthrosurface system] is to eliminate these failures by allowing more accurate bone tunnel placement, utilizing smaller bone tunnels and a more robust suture. These contribute to improving the ease of final implant placement and result in a more consistent repair, " said the company statement.

Self-Cinching Suture Bridge

Carl Hasselman, M.D., from University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania, commented on behalf of the company, “When we looked at the shortfalls in the existing designs we knew that if we could reduce the size of the bone tunnels while providing a stronger suture construct, we could improve patient outcomes considerably. However, I think the most important feature is how we were able to create a self-cinching suture bridge so surgeons can easily adjust the correction angle on each patient individually.”

The system is sterile packaged with completely disposable instrumentation. The small 1.2 mm bone tunnels, says the company, "significantly reduce the stress on the bone caused by larger holes while the low profile plates distribute the load across a larger area.

Spineology Sues Wright Medical Over Reamer Patent

Walter Eisner • Fri, February 27th, 2015

In a lawsuit filed on January 27, 2015 in a Minnesota federal court, Spineology says that in October 2006 it sold Wright Medical 50 of its expandable reamers, "solely for Defendant’s use in procedures for core decompression of the femoral head in avascular necrosis. No license to the ‘757 patent was conveyed to Defendant in that sale."

‘757 Patent

U.S. Patent No. RE42, 757 (the ’757 patent), is entitled “Expandable Reamer” and was reissued on September 27, 2011.

Spineology claims that Wright Medical's X-REAM percutaneous expandable reamer infringes on their ’757 patent. The company also claims the infringement is willful because it sent Wright Medical a cease-and-desist letter in March 2014 and made numerous calls to Wright Medical's lawyers informing them of their alleged infringement and asking for a response.

According to the lawsuit, the only response Spineology received was to be told that Wright Technology was considering the patent infringement allegation. Wright Medical made no defense to Spineology’s allegations, according to the suit.

"Defendant [Wright Medical] has not informed Spineology of any specific grounds for a belief that the claims of the ‘757 Patent were not infringed, were invalid, unenforceable; nor did Defendant provide any other specific reason why it would not be liable for infringement...The acts of infringement by Defendant are willful, intentional, and in conscious disregard of Spineology’ s rights in the ‘757 Patent, " states the lawsuit.

Relief Sought

Spineology is asking the court for a preliminarily judgment and permanently enjoining and restraining Wright Medical from directly infringing, inducing infringement, and/or contributing to the infringement of the ‘757 Patent. The company also wants Wright Medical to pay treble damages for willful infringement. The court is asked to determine damages.